S
Hi,
I just found this amazing site and it has so many devoted participants.
I am new to ISO 13485, and currently helping my company, a new manufacturer, to apply for ISO 13485 certificate. We have only 15 employees so we are trying to do it by ourselves. We want to use just enough resource to build a quality system that meets the ISO 13485 standards.
Can anyone briefly introduce how an audit runs, such as what types of data auditors will collect, how they will interview employees, what they like to see at the site and what they do not like?
I wish I could ask more specific & technical questions but I just could not.
Thanks.
Jimmy Wu
I just found this amazing site and it has so many devoted participants.
I am new to ISO 13485, and currently helping my company, a new manufacturer, to apply for ISO 13485 certificate. We have only 15 employees so we are trying to do it by ourselves. We want to use just enough resource to build a quality system that meets the ISO 13485 standards.
Can anyone briefly introduce how an audit runs, such as what types of data auditors will collect, how they will interview employees, what they like to see at the site and what they do not like?
I wish I could ask more specific & technical questions but I just could not.
Thanks.
Jimmy Wu



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